BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS ZEE CEILING

    MDR report key: 6292233 · Received February 1, 2017

    Report

    Report Number
    2240869-2017-00175
    Event Type
    Malfunction
    Date Received
    February 1, 2017
    Date of Event
    January 5, 2017
    Report Date
    January 9, 2017
    Manufacturer
    SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY
    Product Code
    OWB
    PMA / PMN Number
    K123529
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE X-RAY TUBE IN THAT THE EMITTERS OF THE X-RAY TUBE WERE BROKEN. THE AFFECTED X-RAY TUBE HAS BEEN EXCHANGED AS PART OF THE SERVICE ACTIVITY AND THE SYSTEM WORKS AS SPECIFIED. THE MANUFACTURER IS NOT CONSIDERING FURTHER ACTIONS RESULTING FROM THIS EVENT.

    Additional Manufacturer Narrative · 1

    SIEMENS IS CONDUCTING A THOROUGH INVESTIGATION OF THE REPORTED EVENTS. AS THIS EVENT IS UNDER INVESTIGATION, A ROOT CAUSE HAS NOT YET BEEN DETERMINED. A SUPPLEMENT REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE CEILING SYSTEM. DURING A PATIENT PROCEDURE, THE CUSTOMER REPORTED AN ERROR MESSAGE "DOSE LESS THAN 5%" AND NA X-RAY TUBE ERROR. THE PATIENT WAS SAFELY REMOVED FROM THE SYSTEM AND THE PROCEDURE WAS TERMINATED. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75590 ARTIS ZEE CEILING INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY 10094137

    Patients

    Seq Age Sex Outcome Treatment
    1